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Clinical Research Associate
vor 2 Monaten
Job Summary:
EPM Scientific is seeking a highly skilled Clinical Research Associate to join their team in Saxony, Germany. As a Clinical Research Associate, you will be responsible for conducting site visits, ensuring adherence to study protocols, and maintaining comprehensive study documentation.
Key Responsibilities:
- Site Monitoring: Conduct routine site visits to clinical trial sites, ensuring adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
- Protocol Compliance: Review study documents, including protocols, investigator brochures, and informed consent forms, to ensure consistency and accuracy in study conduct.
- Data Collection and Verification: Oversee data collection processes, including source data verification, case report form (CRF) review, and query resolution, to ensure data accuracy and integrity.
- Safety Reporting: Monitor and report adverse events (AEs) and serious adverse events (SAEs) in accordance with study protocols and regulatory guidelines.
- Study Documentation: Maintain comprehensive study documentation, including monitoring reports, site correspondence, and regulatory submissions, in accordance with company procedures and regulatory requirements.
- Site Relationship Management: Build and maintain effective relationships with investigative sites, study coordinators, and other key stakeholders to facilitate study conduct and ensure timely data collection and reporting.
- Risk Assessment and Mitigation: Identify potential risks to study conduct and data quality and develop proactive strategies to mitigate risks and ensure study success.
- Compliance Oversight: Ensure compliance with study timelines, budgetary constraints, and regulatory requirements throughout the duration of the clinical trial.
Requirements:
- Strong (3+ years preferred) experience in the field of Clinical Operations.
- Relevant associated degree preferred.
- Experience working with Immunotherapy projects is ideal.
- Willingness to travel to sites in Saxony.
